Non-Small Cell Lung CancerSELTICNCT06646770
SEgmentectomy Versus Lobectomy in T1C Non-Small Cell Lung Cancer (SELTIC)
A study testing Segmentectomy and Lobectomy in people with Non-Small Cell Lung Cancer, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to investigate the role of segmentectomy in clinical T1c (2-3 cm) non-small cell lung cancer (NSCLC). The main questions we aim to answer are: 1. Is segmentectomy non-inferior to lobectomy in cT1c NSCLC in terms of overall and recurrence free survival? 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Segmentectomy and Lobectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2025to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical T1c NSCLC
- Parenchymal nodule >2 cm in diameter
- Parenchymal nodule ≤3 cm in diameter
- Consolidation / Tumor Rate (CTR) ≥ 0.50
- Definitive pathological diagnosis of NSCLC preoperative or intraoperatively
- No evidence of distant metastasis
- No evidence of N2 disease
- Adequate pulmonary functions for lobectomy or segmentectomy
Who cannot join
- Pure GGO lesions
- Pathologic diagnosis other than NSCLC
- Technically not suitable for simple or complex segmentectomy, or lobectomy
- Evidence of distant metastasis
- Pathologically confirmed N2 or N3 disease
- Major comorbidity that precludes surgery
- Intraoperative mediastinal nodal dissection of less than 3 lymph node stations
- Prior malignancy in five years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
Istanbul, 34198
Akif Turna, MD, PhD, +905052581581, aturna@iuc.edu.tr
Melek Ağkoç, MD, +905348108485, melek.agkoc1@gmail.com
About this study
Official title: Segmentectomy Versus Lobectomy in Clinical T1c Non-Small Cell Lung Cancer: A Non-Inferiority Trial
The goal of this clinical trial is to investigate the role of segmentectomy in clinical T1c (2-3 cm) non-small cell lung cancer (NSCLC). The main questions we aim to answer are:
- Is segmentectomy non-inferior to lobectomy in cT1c NSCLC in terms of overall and recurrence free survival?
- What are the mortality and morbidity rates of segmentectomy compared to lobectomy?
Read more
Researchers will compare segmentectomy and lobectomy in terms of overall and recurrence free survival.
Participants will:
- Undergo either pulmonary lobectomy or segmentectomy with mediastinal nodal dissection
- Be followed up with a chest CT in every 3 months in first year, every 6 months in second year and every year for following 3 years
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Segmentectomy, Lobectomy
- Keywords
- Non-Small Cell Lung Cancer, T1c, Segmentectomy, Lobectomy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SegmentectomyProcedure or surgery
Pulmonary anatomic segmentectomy with mediastinal nodal dissection via VATS, RATS or open approach.
LobectomyProcedure or surgery
Pulmonary lobectomy with mediastinal nodal dissection via VATS, RATS or open approach.
| Study group | Role | What they receive |
|---|---|---|
| Segmentectomy | Experimental | Pulmonary anatomic segmentectomy with mediastinal nodal dissection Receives: Procedure: Segmentectomy |
| Lobectomy | Active comparator | Pulmonary lobectomy with mediastinal nodal dissection Receives: Procedure: Lobectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Survival
Overall and recurrence free survival
Measured: 5 years
Secondary outcomes (2)
Complication rate associated with surgery
Measured: 90 days
Mortality rate
mortality rate associated with surgery
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start2 Jan 2025 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akif Turna, Istanbul University - Cerrahpasa
- Investigators
- Akif Turna, MD, PhD, Principal investigator, Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646770
- Sponsor's protocol ID
- 2501
- Acronym
- SELTIC
- Status last verified
- Oct 2024
- First submitted
- 16 Oct 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Segmentectomy Versus Lobectomy in Clinical T1c Non-Small Cell Lung Cancer: A Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT06646770
- Acronym / sponsor ID
- SELTIC / 2501
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, T1c, Segmentectomy, Lobectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 2 Jan 2025 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 17 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to investigate the role of segmentectomy in clinical T1c (2-3 cm) non-small cell lung cancer (NSCLC). The main questions we aim to answer are:
- Is segmentectomy non-inferior to lobectomy in cT1c NSCLC in terms of overall and recurrence free survival?
- What are the mortality and morbidity rates of segmentectomy compared to lobectomy?
Researchers will compare segmentectomy and lobectomy in terms of overall and recurrence free survival.
Participants will:
- Undergo either pulmonary lobectomy or segmentectomy with mediastinal nodal dissection
- Be followed up with a chest CT in every 3 months in first year, every 6 months in second year and every year for following 3 years
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Segmentectomy | Experimental | Procedure: SegmentectomyPulmonary anatomic segmentectomy with mediastinal nodal dissection |
| Lobectomy | Active comparator | Procedure: LobectomyPulmonary lobectomy with mediastinal nodal dissection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinical T1c NSCLC
- Parenchymal nodule >2 cm in diameter
- Parenchymal nodule ≤3 cm in diameter
- Consolidation / Tumor Rate (CTR) ≥ 0.50
- Definitive pathological diagnosis of NSCLC preoperative or intraoperatively
Key exclusion criteria (8 listed)
- Pure GGO lesions
- Pathologic diagnosis other than NSCLC
- Technically not suitable for simple or complex segmentectomy, or lobectomy
- Evidence of distant metastasis
- Pathologically confirmed N2 or N3 disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SegmentectomyPulmonary anatomic segmentectomy with mediastinal nodal dissection via VATS, RATS or open approach. | Procedure or surgery | Segmentectomy |
| LobectomyPulmonary lobectomy with mediastinal nodal dissection via VATS, RATS or open approach. | Procedure or surgery | Lobectomy |
Primary outcome
Survival Survival
Time frame: 5 years
Overall and recurrence free survival
2 secondary outcomes
Complication rate associated with surgery
Time frame: 90 days
Mortality rate
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Akif Turna, MD, PhD principal investigator
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Segmentectomy and Lobectomy in people with Non-Small Cell Lung Cancer, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Akif Turna, MD, PhD (+905052581581, aturna@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival Survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.